MAUDE Adverse Event Report: STANMORE IMPLANTS WORLDWIDE HAMMER; LIMB SALVAGE SYSTEM

Catalog Number IMHAM

Device Problem Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 09/15/2018

Event Type  malfunction  

Manufacturer Narrative

It is reported that the hammer end cap became damaged during surgery, there was no delay to surgery and no consequence to patient.The hammer end cap was undamaged when dispatched to the healthcare facility.The exact cause of the event could not be determined, the hammer end cap, that was damaged by the surgeon during use, was replaced by siw upon return of the instrumentation kit.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.Siw will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.

Event Description

It was reported that while operating, one teflon hammer's upper cover is broken (teflon coating) from one side.

• Brand Name: HAMMER
• Type of Device: LIMB SALVAGE SYSTEM
• Manufacturer (Section D): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; GB WD6 3SJ
• Manufacturer (Section G): STANMORE IMPLANTS WORLDWIDE; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3 SJ; GB WD6 3SJ
• Manufacturer Contact: margaret foley ; 210 centennial avenue; centennial park, elstree; borehamwood WD6 3-SJ ; GB WD6 3SJ ; 2082386500
• MDR Report Key: 7959896
• MDR Text Key: 123503647
• Report Number: 3004105610-2018-00096
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IMHAM
• Device Lot Number: B8206
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other